Import Alert 66-10

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 66-10

Published Date: 03/18/2011

Type: DWPE

Import Alert Name:

Chinese Herbal Medicines

Reason for Alert:

Chinese herbal medications have a history, dating back to 1974, of containing strong prescription drugs.

In 1974, four cases of agranulocytosis, resulting in the death of one person and extensive hospitalization of three others, were linked to use of these preparations. FDA analysis of pills involved in the illnesses found phenylbutazone and aminopyrine, and analyses of other "herbal medications" found methyl testosterone, prednisolone, diazepam, chlorzoxazone, and acetaminophen.

In 1980, several illnesses and another death were linked to use of Chinese herbal medications, particularly chuifong toukuwan. Analysis of chuifong toukuwan from various sources found indomethacin, hydrochlorothiazide, chlordiazepoxide, lead, and cadmium.

In 1983, an additional brand of the chuifong toukuwan variety labeled only in Chinese (translated as product number 13 of attachment A below) appeared in the Portland, Oregon area. Trademark is a pair of concentric units surrounding a dragon intertwined about the numeral "7" (Seven Dragon Brand). The pills come 60 to a bag in a white plastic bag with a zip lock closure. FDA analysis has found phenylbutazone at 10 to 18 milligrams per pill in the product.

In 1988, the Food and Drug Branch of the California State Department of Health Services issued a press release announcing an enforcement initiative against dangerous Chinese and other Asian ethnic medicines. Attachment B lists the products involved, the reputed manufacturer, and the hazardous ingredients contained.

Currently, herbal pills are being marketed containing a combination of four drugs: diazepam, indomethacin, hydrochlorothiazide, and mefanamic acid. These pills are marketed under a variety of names and in a variety of packagings. They are spherically shaped, approximately 3/8" in diameter, and have a shiny black exterior. When the pills are cracked open, white crystalline material is observed to be imbedded in the brown interior.

None of the products list the drug substances as ingredients. Investigation has shown that the pills originate from several sources, and usually enter the country via air mail shipments to health food stores, oriental food stores, novelty shops, and individual consumers. They are occasionally sold door to door. These products are listed in attachment A.

Guidance:

Please inform your local U.S. Customs and Postal Service officials of our interest in these types of products, especially mail entries.

Product Description:

Chinese herbal medicines

Charge:

When accompanied by drug claims, charge:

"The article is subject to refusal of admission pursuant to 801(a)(3) in that it appears the labeling fails to bear adequate directions for use for its intended purposes [Misbranded, 502(f)(1)].-

OASIS Charge Code - DIRECTIONS

and

-it appears to be a new dug without an effective new drug application [Unapproved new drug, 505(a)].-

OASIS Charge Code - UNAPPROVED

When unaccompanied by drug claims, charge:

"The article is subject to refusal of admission pursuant to 801(a)(3) in that it appears the labeling fails to bear adequate directions for use for its intended purposes [Misbranded, 502(f)(1)].-

Desc:Sleeping Buddha; Happy Buddha; Chinese Influ-X. Notes:Distributor for Mei Kang Tang (FEI number 3001374920). 3/6/1998 Examination of
a sample of Sleeping Buddha; 90 mg capsules by Seattle District found 1.24 mg
of undeclared Estazolam. Estazolam is in the prescription drug class of
benzodiazepines and is a C-IV schedule drug. If consumed during pregnancy; the
drug can cause serious adverse effects on the developing fetus; including
congenital malformations and depression of the central nervous system.
Canadian officials tested Happy Buddha and Chinese Influ-X and determined
Happy Buddha contained undeclared chlorpheniramine and the Chinese Influ-X
contained undeclared chlorpheniramine and acetaminophen.

Desc:Chinese Chufeng Toukawwan Notes:This drug makes unproven treatment claims for serious medical conditions. Drugs which make these claims may not be sold without a doctor's prescription.

China National Chemicals I/E Corp

Date Published : 10/02/2009

Kwang Chow Branch
, Kwang Chow,
CHINA

66 - - - -- Human and Animal Drugs

Date Published: 10/02/2009

Desc:Lingzhi Co. Tablets Notes:This drug makes unproven treatment claims for serious medical conditions. Drugs which make these claims may not be sold without a doctor's prescription.

China National Medicine and Health Products I/E Corp

Date Published : 10/02/2009

unknown , Guangxi Branch
, Guangxi,
CHINA

66 - - - -- Human and Animal Drugs

Date Published: 10/02/2009

Desc:Moschus fel Ursi Chufeng Toukuwan

China National Native Produce & Animal By-Products

Date Published : 10/02/2009

Unknown Street
, Shandung,
Qingdao CHINA

66 - - - -- Human and Animal Drugs

Date Published: 10/02/2009

Desc:Yu Gong Hui Li Wan Notes:This drug makes unproven treatment claims for serious medical conditions. Drugs which make these claims may not be sold without a doctor's prescription.

Fitshan Hang Chun Medicine Factory

Date Published : 10/02/2009

unknown
, Fitshan,
CHINA

66 - - - -- Human and Animal Drugs

Date Published: 10/02/2009

Desc:Superior Sore Throat Powder Spray Notes:This drug makes unproven treatment claims for serious medical conditions. Drugs which make these claims may not be sold without a doctor's prescription.

Fu Sung Pharmaceutaical Works

Date Published : 10/02/2009

unknown
, Unknown,
CHINA

66 - - - -- Human and Animal Drugs

Date Published: 10/02/2009

Desc:Huku Wan Notes:This drug makes unproven treatment claims for serious medical conditions.
Drugs which make these claims may not be sold without a doctor's prescription.

Guangzhou Chenliji Pharmacy

Date Published : 10/02/2009

194 Beijing Rd
, Guangzhou,
CHINA

31 K - - 99 Tea, N.E.C.

Date Published: 10/02/2009

Desc:Da Huo Luo Wan Notes:12/5/1995. Unproven claims that the product is indicated for arthralgia and limited mobility due to rheumatism.

31 P - - 99 Tea Substitutes, N.E.C.

Date Published: 10/02/2009

Desc:Da Huo Lua Wan Notes:12/5/1995. Unproven claims that the product is indicated for arthralgia and limited mobility due to rheumatism

54 E - - 99 Herbals & Botanical Teas, N.E.C.

Date Published: 10/02/2009

Desc:Da Huo Luo Wan Notes:12/5/1995. Unproven claims that the product is indicated for arthralgia and limited mobility due to rheumatism

54 F - - 08 Enchinacea, Herbal & Botanicals (not teas)

Date Published: 10/02/2009

Desc:Da Huo Luo Wan Notes:12/5/1995. Unproven claims that the product is indicated for arthralgia and limited mobility due to rheumatism

HENAN YILONG IMPORT & EXPORT CO. LTD

Date Published : 10/02/2009

84 Hongzhuan Road
, ZHENGZHOU,
CHINA

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 10/02/2009

Desc:Liqiang 4 Herbal Supplements (AKA Liqiang Xiao Ke Ling) Notes:8/16/2005. Shipper for Liqiang Research Institute. FDA Analysis confirmed the product contained glyburide which is a prescription drug used to lower blood sugar and can cause serious; life threatening consequences in some people. On 7/01/2005; FDA issues a nationwide alert to consumers due to the potential health risks of the product. The product has been recalled.

Desc:Yunnan Produce Tienchi Pill Raw Notes:This drug makes unproven treatment claims for serious medical conditions. Drugs which make these claims may not be sold without a doctor's prescription.

Kwangchow United Manufactory of Chinese Medicine

Date Published : 10/02/2009

unknown
, Kwangchow,
CHINA

66 - - - -- Human and Animal Drugs

Date Published: 10/02/2009

Desc:Specific Juk Tsyn Wan Notes:This drug makes unproven treatment claims for serious medical conditions. Drugs which make these claims may not be sold without a doctor's prescription.

LIQIANG RESEARCH INSTITUTE

Date Published : 10/02/2009

2 Zheng Bian Road, , Qi Li He Qiao Tou
, ZHENGZHOU,
CN-41 CHINA

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 10/02/2009

Desc:Liqiang 4 Herbal Supplements (AKA Liqiang Xiao Ke Ling) Notes:8/16/2005. FDA Analysis confirmed the product contained glyburide which is a
prescription drug used to lower blood sugar and can cause serious; life
threatening consequences in some people. On 7/01/2005; FDA issues a nationwide
alert to consumers due to the potential health risks of the product. The
product has been recalled.

Lanchow Chinese Medicine Works

Date Published : 10/02/2009

UNKNOWN
, Lanchow,
CHINA

66 - - - -- Human and Animal Drugs

Date Published: 10/02/2009

Desc:Chh Pai Pa Wei Wan Notes:This drug makes unproven treatment claims for serious medical conditions. Drugs which make these claims may not be sold without a doctor's prescription.

Desc:Sleeping Buddha; Happy Buddha; Chinese Influ-X Notes:3/6/1998 Examination of a sample of Sleeping Buddha; 90 mg capsules by Seattle
District found 1.24 mg of undeclared Estazolam. Estazolam is in the
prescription drug class of benzodiazepines and is a C-IV schedule drug. If
consumed during pregnancy; the drug can cause serious adverse effects on the
developing fetus; including congenital malformations and depression of the
central nervous system. Canadian officials tested Happy Buddha and Chinese
Influ-X and determined Happy Buddha contained undeclared chlorpheniramine and
the Chinese Influ-X contained undeclared chlorpheniramine and acetaminophen.

Desc:Yang Hsin Ning Shen Wan Notes:This drug makes unproven treatment claims for serious medical conditions. Drugs which make these claims may not be sold without a doctor's prescription.

66 V - - 99 Miscellaneous Patent Medicines, Etc.

Date Published: 10/02/2009

Desc:Hui Chin Tan

Tianjin Tianyao Pharmaceuticals Co.

Date Published : 10/02/2009

91 Cheng Lin Zhuang Road, Hedong Dist
, Tianjin, Prc,
CHINA

66 - - - -- Human and Animal Drugs

Date Published: 10/02/2009

Desc:Hi Huan Chang Ya Wan Notes:This drug makes unproven treatment claims for serious medical conditions. Drugs which make these claims may not be sold without a doctor's prescription.

Tientsin Drug Manufactory

Date Published : 10/02/2009

unknown
, Tientsin,
CHINA

66 - - - -- Human and Animal Drugs

Date Published: 10/02/2009

Desc:Dendrobium Moniliforme Night Sight Pills Notes:This drug makes unproven treatment claims for serious medical conditions. Drugs which make these claims may not be sold without a doctor's prescription.

Tsinan People's Medicine Works

Date Published : 10/02/2009

unknown
, Tsinan,
CHINA

66 - - - -- Human and Animal Drugs

Date Published: 10/02/2009

Desc:Dendrobium Moniliforme Night Sight Pills Notes:This drug makes unproven treatment claims for serious medical conditions. Drugs which make these claims may not be sold without a doctor's prescription.

Tsingtao Medicine Works

Date Published : 10/02/2009

unknown
, Tsingtao,
CHINA

66 - - - -- Human and Animal Drugs

Date Published: 10/02/2009

Desc:Wei Ti Ling Notes:This drug makes unproven treatment claims for serious medical conditions.
Drugs which make these claims may not be sold without a doctor's prescription.

Tsingtao Pharmaceutical Works

Date Published : 10/02/2009

unknown
, Tsingatao,
CHINA

66 - - - -- Human and Animal Drugs

Date Published: 10/02/2009

Desc:Liden Tablets Notes:This drug makes unproven treatment claims for serious medical conditions.
Drugs which make these claims may not be sold without a doctor's prescription.

United Pharmaceutical Mfty.

Date Published : 10/02/2009

255 Dong Feng Road W.,
, Guangzhou,
CHINA

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)

Date Published: 10/02/2009

Desc:Pe Min Kan Wan Tablets (Herbal) Notes:8/11/1999. GPI = Dr. FDA examination of two samples of this product revealed the presense of undeclared Chlorpheniramine Maleate. Products were labeled in both Chinese and English; and were labeled and represented as Herbal Products.

66 - - - -- Human and Animal Drugs

Date Published: 10/02/2009

Desc:Pe Min Kan Wan Tablets (Herbal) Notes:8/11/1999. GPI = Dr. FDA examination of two samples of this product revealed the presense of undeclared Chlorpheniramine Maleate. Products were labeled in both Chinese and English; and were labeled and represented as Herbal Products.

66 - - - -- Human and Animal Drugs

Date Published: 10/02/2009

Desc:Huku Wan Tiger Bone Pills Notes:This drug makes unproven treatment claims for serious medical conditions. Drugs which make these claims may not be sold without a doctor's prescription.

Yulin Drug Manufacturing

Date Published : 10/02/2009

Guchen Road, Nanning
, Guangxi, China,
CHINA

66 - - - -- Human and Animal Drugs

Date Published: 10/02/2009

Desc:Jiguacao Wan Notes:This drug makes unproven treatment claims for serious medical conditions.
Drugs which make these claims may not be sold without a doctor's prescription.

Desc:Chong Ro Whan Herbal Anti-Diarrheal Notes:Examination of a sample by FDA Cincinnati District Laboratoy confirmed the presence of Tetrahydropalatine. This ingredian is not included in the ingrediant statement on the product label. Medical claims listed for uses of the product include in part anodyne; sedative spasm...insomnia due to pain....gastric and duodenal ulcer pains stomach neuralgia; pain in shrunken womb after childbirth. Nervous insomnia; spasmodic cough...